Yu Zhu, Chen Li, Liming Chen, Haiyan Liu, Lun Ou, Tong Li, Xuan Wang, Tenghua Wang, Jingyuan Tian, Xintong Liang, Zhiqin Hu, Yaoxuan Zhan, Shuangshuang Xiao, Xiaole Wang, Yongmei Li, Jin He, Qingshan Zheng, Haifeng Song, Xianbo Li, Yi Fang
BACKGROUND AND OBJECTIVE: GB221 is a recombinant humanized anti-HER2 monoclonal antibody. The purpose of this study was to evaluate the pharmacokinetic, safety, and immunogenicity of GB221 in healthy Chinese adults in comparison to trastuzumab (Herceptin® ). METHODS: In this randomized, double-blind, parallel-group phase I clinical trial, 88 subjects were randomized 1:1 to receive a single intravenous infusion (90-100 min) of GB221 or trastuzumab (6 mg/kg)...
April 2, 2024: European Journal of Drug Metabolism and Pharmacokinetics